Ann: Update - CE Marking Application, page-73

In a September Bell Potter report on OSL it clearly highlighted the risks of getting approval. I can't see how they will avoid having to do a large randomised study when even its quoted below the data from the PanCo study is suggestive that Oncosil in combination with chemotherapy can control the progression of tumours within the pancreas.

"IQVIA (formerly Quintiles IMS) are a specialist healthcare consulting firm. Their role in the UK and across Europe will be to assist Oncosil to access pools of funding. In the UK, funding for new devices can be haphazard, particularly in the case of Oncosil where use of the product is not supported by evidence from a large randomised study or a NICE recommendation. "

"FUTURE CLINICAL DIRECTION Long term adoption will ultimately depend upon survival data from a large randomised study. The form of the study or studies is yet to be determined as the company awaits engagement with the regulators in Europe and the US before committing to a pivotal study design. The data from the PanCo study is suggestive that Oncosil in combination with chemotherapy can control the progression of tumours within the pancreas, however randomised data is necessary to confirm the incremental effect of Oncosil over chemotherapy alone for overall survival. At some point the company will have to run this survival benefit study but it is probably not the first option. We expect the company will use the data from the both the European and US trial in future discussions with regulators. The company has been silent on its intended regulatory pathway in the US beyond the current OncoPac1 trial. Ideally the company will run further studies with the objective of obtaining an FDA approval in the shortest possible time frame. We speculate this trial may target borderline resection patients with the goal of downsizing tumours for surgery (as a surrogate marker). Alternatively the company may pursue a smaller randomised study not dissimilar to PanCo – except with a control arm. In this case the FDA may accept localised progression free survival or overall response rate as a surrogate marker of survival. We note that Merck’s blockbuster Pemrolizumab obtained its first accelerated approval (in melanoma) based on overall response rate. Either way the absence of any breakthrough in the treatment of advance pancreatic disease for more than a decade is sufficient reason to pursue an accelerated approval, provided of course the clinical data is supportive."